Long research journey to clinical trial

University of Auckland researchers will soon begin a world first clinical trial to test whether a well-known drug can improve the prospects of babies who grow poorly in the womb.

A co-investigator on the study is Professor Philip Baker, Director of the Centre of Research Excellence, Gravida: National Centre for Growth and Development, and Professor of Maternal and Fetal Health at the Liggins Institute.

For more than 15 years he has been involved in laboratory and animal studies, amassing evidence that sildenafil, often referred to by the brand name Viagra, may increase the growth rates of very small babies in the womb helping them to be born safely at a later gestation and a larger, healthier size.

Sildenafil citrate is best known for its effects on the blood supply to the male pelvis. However Professor Baker hypothesised that it could have a similar effect on pregnant women increasing the flow of blood, carrying life-giving oxygen and nutrients, to the womb and developing baby.

“We are getting towards the end of what has been a very long research programme,” Prof. Baker says. “Medical breakthroughs rarely happen overnight but are the result of years of thought, effort and energy. This particular trial will run for several years, and then the results will take time to collate, quantify and publish.

“We’ve reached a point where the volume of pre-clinical evidence is compelling and we want to translate these findings into genuine patient benefit. So across the world, different teams of investigators are working to assemble a network of trials which together will provide a definitive answer.”

The multi-centre clinical Australasian trial will be led by Gravida investigator Dr Katie Groom in The University of Auckland Department of Obstetrics and Gynaecology. More than 120 women will be recruited to the double blind randomised placebo controlled trial from centres across New Zealand and Australia over the next three years.

Eligible women will be identified by their obstetrician prior to 30 weeks of pregnancy. The drug will only be administered to mothers with extreme cases of intrauterine growth restriction who are under close obstetric care and already likely to be hospital in-patients.

Safety is a major concern for this trial and researchers warn that under no circumstances should pregnant women outside the trial take the drug.

The trial is funded by the Health Research Council of NZ and Gravida: National Centre for Growth and development.

Visit www.gravida.org.nz for more information